Product Info

The Meddev Solutions EU MDR Guidebook

With the EU Medical Device Regulation (MDR) looming and requiring implementation by May 2020, we have created a guidebook and training course to help you get prepared.

For anyone involved in ensuring compliance with the EU MDR, it is the ‘go-to’ reference and tool kit, intended to be your companion to reference time and time again.

It contains a number of useful tools and tables to guide you through the MDR, such as:

  • device classification and their differences from the MDD

  • QMS requirements and how they align with ISO 13485

  • technical documentation requirements

  • clinical data requirements, including a handy checklist

  • general safety and performance requirements tables

  • annex and article guide

Front cover Meddev MDR Book 2018 Hi Res
380 Pages
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"An essential tool for any device manufacturer selling into Europe!"

"A very well presented course with excellent examples throughout, the Guidebook is the cherry on the cake!"

Don't forget: Our 2-day Medical Device Regulation (MDR) training course includes your own copy of the MDR Guidebook to take away! View available dates here

E-book available now!

The Regulatory Affairs Professionals Society (RAPS) has teamed up with us to offer our MDR Guidebook in a convenient e-book format.

RAPS Member: $175
Non-member:  $225

*Note: Internet access is required to read all RAPS e-books. E-books cannot be downloaded for offline use. 

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